Dein persönlicher KI-Karriere-Agent
Senior Manager Biostatistics(m/w/x)
Developing biostatistical strategies and reviewing clinical study designs for pharmaceutical/biotechnology firms. 5+ years of CRO or industry experience required. Work in international, multidisciplinary teams on challenging scientific projects.
Anforderungen
- University degree in (Bio-)statistics or mathematics or equivalent
- At least 5 years experience in CROs and/or pharmaceutical/biotechnology industry
- Enjoyment of challenging scientific projects in international and multidisciplinary teams
- Passion for clinical development and analysis
- Comprehensive knowledge of statistical methodology in clinical research
- Motivation to explore and implement AI-supported methods
- Knowledge of Real-World research methodology
- Experience in PK/PD studies (BE studies) / adaptive designs is a plus
- Excellent knowledge of SAS
- Knowledge of R programming is a plus
- Solid understanding & implementation of CDISC requirements
- Strong communication skills for presenting methodology
- Fluent English (written & spoken)
Aufgaben
- Manage biostatistical solutions and strategies
- Review pre-clinical and clinical studies
- Ensure quality control for company-sponsored trials
- Guide contract research organizations
- Plan study designs and sample sizes
- Develop statistical analysis plans
- Conduct statistical analyses
- Interpret statistical results
- Contribute to clinical study reports
- Create integrated summaries for submissions
- Participate in CRF development
- Develop edit check specifications
- Create data validation plans
- Maintain programming tool standards
- Document and validate programming outputs
- Statistically program quality control outputs
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- SAS
- R
- CDISC
- ADaM
- Home
- Jobs in Deutschland
- Bad Homburg vor der Hoehe
- Senior Manager BiostatisticsSenior Manager Biostatistics bei Fresenius Kabi
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Vollzeitnur vor OrtSeniorBad Homburg vor der Höheab USD 120.000 - 160.000 / Jahr
- Home
- Jobs in Deutschland
- Bad Homburg vor der Hoehe
- Senior Manager BiostatisticsSenior Manager Biostatistics bei Fresenius Kabi
Senior Manager Biostatistics(m/w/x)
Developing biostatistical strategies and reviewing clinical study designs for pharmaceutical/biotechnology firms. 5+ years of CRO or industry experience required. Work in international, multidisciplinary teams on challenging scientific projects.
Anforderungen
- University degree in (Bio-)statistics or mathematics or equivalent
- At least 5 years experience in CROs and/or pharmaceutical/biotechnology industry
- Enjoyment of challenging scientific projects in international and multidisciplinary teams
- Passion for clinical development and analysis
- Comprehensive knowledge of statistical methodology in clinical research
- Motivation to explore and implement AI-supported methods
- Knowledge of Real-World research methodology
- Experience in PK/PD studies (BE studies) / adaptive designs is a plus
- Excellent knowledge of SAS
- Knowledge of R programming is a plus
- Solid understanding & implementation of CDISC requirements
- Strong communication skills for presenting methodology
- Fluent English (written & spoken)
Aufgaben
- Manage biostatistical solutions and strategies
- Review pre-clinical and clinical studies
- Ensure quality control for company-sponsored trials
- Guide contract research organizations
- Plan study designs and sample sizes
- Develop statistical analysis plans
- Conduct statistical analyses
- Interpret statistical results
- Contribute to clinical study reports
- Create integrated summaries for submissions
- Participate in CRF development
- Develop edit check specifications
- Create data validation plans
- Maintain programming tool standards
- Document and validate programming outputs
- Statistically program quality control outputs
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Tools & Technologien
- SAS
- R
- CDISC
- ADaM
Über das Unternehmen
Fresenius Kabi
Branche
Pharmaceuticals
Beschreibung
The company is dedicated to ensuring the excellence of packaging materials for life-saving products.
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